Evidence map›Paper›PMID 22753773›Full record

Trial reportRheumatology (Oxford, England)2012

Improvements in health-related quality of life after treatment with tocilizumab in patients with rheumatoid arthritis refractory to tumour necrosis factor inhibitors: results from the 24-week randomized controlled RADIATE study.

Vibeke Strand, Gerd R Burmester, Sarika Ogale, Jenny Devenport, Ani John, Paul Emery

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Rheumatology (Oxford, England), 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00106522 (A Randomized, Double-blind Study of Safety and Reduction in Signs and Symptoms During Treatment With Tocilizumab Versus Placebo, in Combination With Methotrexate, in Patients With Moderate to Severe Active Rheumatoid Arthritis and Inadequate Response to Anti-TNF Therapy), which is not on this map. Cited by 55 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
55citing papers in PubMed, 6 pooled it
7.6field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00106522 phase3completednot on this map

A Randomized, Double-blind Study of Safety and Reduction in Signs and Symptoms During Treatment With Tocilizumab Versus Placebo, in Combination With Methotrexate, in Patients With Moderate to Severe Active Rheumatoid Arthritis and Inadequate Response to Anti-TNF Therapy

TypeinterventionalSponsorHoffmann-La RocheRan2005 to 2007Enrolled499ConditionsRheumatoid ArthritisArmsMethotrexate, Placebo, tocilizumab [RoActemra/Actemra]
3 · Its place in the literature

Who cites it

55 citing papers in PubMed, 6 syntheses or guidelines pooled it, 104 citations in OpenAlex.

  1. Pooled it
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  5. Biologic interventions for fatigue in rheumatoid arthritis.The Cochrane database of systematic reviews · 2016
    Pooled it
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  17. Pain mechanism and management strategy of rheumatoid arthritis.Frontiers in pain research (Lausanne, Switzerland) · 2025
    Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 1 institution in 2 countries.

Vibeke StrandDivision of Immunology, Stanford University, 306 Ramona Road, Portola Valley, CA 94028, USA. vstrand@stanford.edu
Gerd R Burmester
Sarika Ogale
Jenny Devenport
Ani John
Paul Emery
University of Leeds · GB

Funding

Versus Arthritis 18475
6 · The paper itself

Abstract

objectiveTo investigate the effect of tocilizumab on patient-reported outcomes (PROs) in RA patients with inadequate responses to TNF inhibitors (TNFis).

methodsIn a Phase III randomized controlled trial, 489 patients received 4 or 8 mg/kg tocilizumab or placebo every 4 weeks plus MTX for 24 weeks. Mean changes from baseline over time and proportions of patients reporting improvements greater than or equal to minimum clinically important differences (MCIDs) in PROs were analyzed.

resultsAt week 24, 8 mg/kg resulted in significantly greater improvements vs placebo in pain, global assessment of disease activity (P=0.001), Health Assessment Questionnaire-Disability Index (HAQ-DI; P<0.0001), Functional Assessment of Chronic Illness Therapy-Fatigue (P=0.0150) and Medical Outcomes Survey Short Form 36 (SF-36 v2) Physical Component Summary (PCS; P=0.0003) scores, all greater than MCID; 4 mg/kg resulted in greater improvements in pain (P=0.0100), HAQ-DI (P=0.0030) and SF-36 PCS (P = 0.0020) scores. Tocilizumab-associated improvements were evident as early as week 2. At week 24, more tocilizumab-treated than control patients reported improvements greater than or equal to MCID in SF-36 domain scores and related PROs (50.9-84.9% vs 35.0-51.7%) and achieved ACR50 responses and/or Disease Activity Score 28 (DAS28) remission with PRO improvements greater than or equal to MCID (36.2-51.2% vs 10-20.7% and 10.7-37.5% vs 0.0-3.4%, respectively).

conclusionTocilizumab treatment in patients with inadequate responses to TNFis resulted in rapid and sustained improvements in multiple PROs that were statistically significant and clinically meaningful, consistent with previous efficacy reports. Trial Registration. ClinicalTrials.gov, http://clinicaltrials.gov/, NCT00106522.

Indexed as

Quality of LifeAdultAgedAntibodies, Monoclonal, HumanizedAntirheumatic AgentsArthritis, RheumatoidDisability EvaluationDrug Therapy, CombinationFemaleHealth StatusHumansMaleMethotrexateMiddle AgedPainPain MeasurementAntibodies, Monoclonal, HumanizedAntirheumatic AgentsMethotrexatetocilizumab

Identifiers

PMID22753773
PMCPMC3448882
OpenAlexW2118449404

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.